Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT07762755
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Coronary Atherosclerosis
  • Hyperlipidaemia
  • Hypertriglyceridaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • icosapent ethyl (IPE) — DRUG
    Icosapent ethyl will be administered orally at a dose of 2 g twice daily (total daily dose of 4 g) for 12 months, in addition to stable LDL-C-lowering therapy.
  • Standard LDL-C-Lowering Therapy — DRUG
    Participants will continue an individualized, stable LDL-C-lowering regimen throughout the 12-month study period. The LDL-C-lowering regimen must have remained stable for more than 4 weeks before randomization. This background therapy will be administered in both study arms.

Study Details

This randomized controlled study will evaluate whether icosapent ethyl (IPE) can improve and stabilize high-risk coronary plaques in patients receiving stable low-density lipoprotein cholesterol (LDL-C)-lowering therapy. Potential participants will have coronary plaques identified by coronary computed tomography angiography (CCTA), with 30% to 70% narrowing in at least one major coronary artery and at least one high-risk plaque feature. After baseline imaging with fluorine-18 sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT), eligible participants will be randomly assigned in a 1:1 ratio to receive either IPE 2 g twice daily plus standard LDL-C-lowering therapy or standard LDL-C-lowering therapy alone for 12 months. At the end of treatment, participants will undergo repeat CCTA and 18F-NaF PET/CT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.

Key Dates

First listed
Aug 13, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Icosapent Ethyl Plus Standard LDL-C-Lowering Therapy
    Participants will receive oral icosapent ethyl 2 g twice daily for 12 months in addition to their stable LDL-C-lowering therapy. CCTA and 18F-NaF PET/CT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.
  • Active Comparator: Standard LDL-C-Lowering Therapy Alone
    Participants will continue their stable LDL-C-lowering therapy for 12 months without receiving icosapent ethyl. CCTA and 18F-NaF PET/CT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.

Primary Outcome Measure

Absolute Change From Baseline in Maximum Target-to-Background Ratio of the Target Coronary Lesion [ Time Frame: Baseline and Month 12 ]

Central Contacts

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